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Serving leading biopharmaceutical companies globally:

Julphar
Cantor Fitzgerald
Citi
McKinsey
Harvard Business School
QuintilesIMS
Federal Trade Commission
Express Scripts
UBS
US Army

Generated: November 18, 2017

DrugPatentWatch Database Preview

Drug Master Files for: leuprolide

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DMF No. Status Type Submission Date Holder Subject
4476III1/25/1982TAKEDA CHEMICAL INDUSTRIES LTDTAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION
6142III12/23/1985TAKEDA CHEMICAL INDUSTRIES LTDTAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE)
10416AII8/13/1993TAKEDA PHARMACEUTICAL CO LTDLEUPROLIDE ACETATE
11236AII12/8/1994BACHEM AMERICAS INCLEUPROLIDE ACETATE
12052III7/18/1996MALLINCKRODT INCLEUPROLIDE ACETATE
13150AII8/21/1998POLYPEPTIDE LABORATORIES INCLEUPROLIDE
13822AII11/6/1998BACHEM AGLEUPROLIDE ACETATE
13922III12/29/1998PENINSULA LABS INCLEUPROLIDE
14440III10/8/1999GENZYME CORPLEUPROLIDE ACETATE
14763AII3/7/2000CHEMI SPALEUPROLIDE ACETATE
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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Deloitte
Chubb
Mallinckrodt
Cantor Fitzgerald
Julphar
Cipla
Federal Trade Commission
Covington
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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